Funded Projects

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Project # Sort descending	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s)	Location(s)	Year Awarded
1R43DA049620-01	NeoGUARD: An easy-to-use, low-cost brain monitor for objective screening and treatment of opioid-exposed infants	Cross-Cutting Research	Small Business Programs	NIDA	NEUROWAVE SYSTEMS, INC.	Zikov, Tatjana None	Cleveland Hights, OH	2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional) NOFO Number: RFA-DA-19-019 Summary: Neonatal Opioid Withdrawal Syndrome (NOWS) affects a growing number of neonates each year due to the ongoing opioid epidemic ravaging the United States. Complex neurobehavioral observation of newborns is the primary modality used. It is subjective and time-consuming by nature, requires significant expertise, and can lead to delays in treatment. The goal of this project is to develop an innovative, low-cost, non-invasive, and easy-to-use brain monitor to objectively assess the severity of withdrawal symptoms in newborns exposed to opioids and provide evidence-based decision support to care providers to improve both short- and long-term developmental outcomes. This device, referred to as NeoGUARD, is based on the continuous, automated, and real-time monitoring of brain function to detect EEG abnormalities shown to be related to NOWS and determine severity to guide pharmacological intervention. This study will focus on the initial prototyping and refinement of the hardware and software, as well as initial evaluations of its use.
1R43DA049623-01	Non-invasive Neuromodulation Device for Decreasing Withdrawal Symptoms and Craving during Treatment of Opioid Use Disorder	Cross-Cutting Research	Small Business Programs	NIDA	THERANOVA, LLC	JAASMA, MICHAEL	San Francisco, CA	2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional) NOFO Number: RFA-DA-19-019 Summary: Opioid use disorder (OUD) can be lethal, with opioid overdose causing more than 115 deaths in the U.S. each day. Although medications are effective at reducing illicit opioid use and overdose deaths, it is well-established that withdrawal and craving are highest in the initial weeks, making this a high-risk period for treatment dropout, relapse, and overdose. Adjunct therapies that can reduce early opioid withdrawal and craving may improve retention in treatment with buprenorphine-naloxone, and recent research has shown that stimulation of a peripheral nerve significantly modulates withdrawal- and craving-related responses for opioids and other drugs. This project will test the effectiveness of the EMPOWER Neuromodulation System, a portable, non-invasive transcutaneous electrical nerve stimulation (TENS) device developed by TheraNova for the treatment of OUD.
1R43DA049650-01	Patient-level Risk Identifier Models for a Multifactor Opioid Abuse Risk Assessment Strategy	Cross-Cutting Research	Small Business Programs	NIDA	PRINCIPLED STRATEGIES, INC.	DuBose, Paul	ENCINITAS, CA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: This project, a partnership with Principled Strategies, will develop innovative, patient-level models for opioid risk identification and integrate them into the SafeUseNow managed care system—an actionable solution for combating prescription drug abuse that currently operates at the prescriber level only. Incorporating patient-level risk identifier models will strengthen an already powerful and demonstrably effective program and constitutes a critical step in generating a first-in-class, multifactor risk assessment strategy that is truly holistic. Using a variety of data sources, advanced analytics, and multiple empirically validated risk identification models, the groundbreaking advancement in SafeUseNow technology will enable health care stakeholders to identify combinations of prescribers, patients, and pharmacies whose behaviors may contribute to prescription drug abuse. This project will work to obtain new datasets for analysis, assess them, and use them to build national patient-level risk models for relevant outcomes, which will enable the development and evaluation of a next-generation prototype for a patient-level version of SafeUseNow.
1R43DA049684-01	Non-intrusive detection of temporary neurologic impairment by opioids	Cross-Cutting Research	Small Business Programs	NIDA	ZXEREX CORPORATION	BESSERMAN, RICHARD	Scottsdale, AZ	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) NOFO Number: PA-18-573 Summary: With the exception of the Breathalyzer for alcohol, there is currently no available technology that can immediately identify neurologic impairment related to the use of licit or illicit drugs. The presently available methods for detecting opioids—which rely upon analysis of urine, blood, saliva, or hair—are expensive, time-consuming to implement, and can take days to deliver actionable information to meet the “fitness-for-duty” concerns of employers as well as the needs for immediate detection of drug use in the drug rehabilitation and public safety fields. This project intends to develop a non-invasive means of identifying temporary neurological impairment from prescription opioids using analysis of involuntary eye movements. The resultant biometric signature of opioid impairment will be incorporated into Zverex’s existing product library of oculomotor biosignatures, such as marijuana impairment and fatigue.
1R43DA050338-01	A universal approach for improving the limit of detection for fentanyl and fentanyl derivatives in urine	Cross-Cutting Research	Small Business Programs	NIDA	CERES NANOSCIENCES, LLLP	LEPENE, BENJAMIN SCOTT	MANASSAS, VA	2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional) NOFO Number: RFA-DA-19-019
1R43DA050349-01	A Novel Chemokine Receptor Antagonist to Block Opioid Reinforcement, Relapse and Physical Dependence	Cross-Cutting Research	Small Business Programs	NIDA	CREATIVE BIO-PEPTIDES, INC.	RUFF, MICHAEL	Potomac, MD	2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional) NOFO Number: RFA-DA-19-019 Summary: Current agonist treatments for opioid use disorder (OUD) are not adequate to address the opioid crisis and have abuse liability concerns. Chemokines (hormones of the immune system that mediate innate immune inflammation) enhance pain, reduce opioid analgesia, and promote drug-seeking behavior and addiction—giving them a central role at the crossroads of chronic pain and the opioid crisis. So blocking chemokines (rather than opioid receptors) provides an exciting and untested treatment opportunity for pain and OUD. This proposal will assess, in animal self-administration models that mimic human drug-taking, whether a chemokine antagonist peptide R103 reduces morphine intake, as well as if R103 will prevent or blunt naloxone-precipitated withdrawal signs in morphine-dependent rats and stop relapse.
1R43DA050358-01	A Project to Test The Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders	Cross-Cutting Research	Small Business Programs	NIDA	MINDLIGHT, LLC	SCHIFFER, FREDRIC (contact); TEICHER, MARTIN H	Newton, MA	2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional) NOFO Number: RFA-DA-19-019 Summary: This project aims to demonstrate the safety and effectiveness of a novel treatment for opiate addiction using a technique called photobiomodulation, application of light to the forehead. The treatment consists of using a 4-minute application of transcranial photobiomodulation, near-infrared mode, through a supra-luminous LED, to one side of the forehead over the brain hemisphere that has been determined to have a more positive emotional valence. The study will examine differences in opioid cravings, anxiety, depression, and opioid use between participants receiving the treatment and those receiving a sham treatment. We will evaluate patients weekly for safety and efficacy for 3 weeks post-treatment. In Aim II, a highly-regarded product engineer will work with the company to design a marketable product that may have patentable elements.
1R43DA050360-01	Transcutaneous auricular neurostimulation for neonatal abstinence syndrome	Cross-Cutting Research	Small Business Programs	NIDA	SPARK BIOMEDICAL INC	KHODAPARAST, NAVID (contact); JENKINS, DOROTHEA DENISE	Friendswood, TX	2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional) NOFO Number: RFA-DA-19-019 Summary: As of 2012, an infant with neonatal abstinence syndrome (NAS) was born every 25 minutes in the United States, accounting for more than $1.5 billion in national health care expenditures. These infants frequently require hospital stay in a neonatal intensive care unit (NICU), with an average hospital stay of 25 days at an average treatment cost of $66,000. Treatment of NAS usually follows a multimodal regime based on drug therapy with an oral morphine solution, mostly in combination with a sedative, but there is a need for nonpharmacological approaches. This project will test a transcutaneous auricular neurostimulation device to help NAS babies recover from opioid withdrawal without harmful side effects. The non-invasive, auricular neurostimulation device will be placed around the ear (similar to a hearing aid), and stimulation will be delivered transcutaneously.
1R43DA050380-01	Neurofeedback-EEG-VR (NEVR) System for Non-opioid Pain Therapy	Cross-Cutting Research	Small Business Programs	NIDA	QUASAR, INC.	ROBERTS, BROOKE	San Diego, CA	2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional) NOFO Number: RFA-DA-19-019 Summary: Pain is one of the most common and debilitating symptoms of a wide range of injuries and diseases. Safe and effective alternatives for treating pain that reduce dependence on opioids are, therefore, a primary goal of the NIH. This project proposes a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback (NF) solution in an immersive virtual reality (VR) environment. NF and VR have been shown to independently produce ameliorative effects on pain, and it is hypothesized that an NF training in VR would have synergistic effects, as VR would distract from pain perception to improve patient compliance in more engaging NF protocols that improve their ability to control pain perception. In the scope of this project, we will initially focus our work on chronic low back pain (cLBP), as this is a growing segment of chronic pain sufferers with a 39 percent worldwide lifetime prevalence, and whose sufferers have historically been heavy users of opiates; later stages of this project will expand this application to address other forms of pain.
1R43DA050393-01	Evaluation of the therapeutic potential of exclusive antagonists of extrasynaptic NMDA receptors for treatment of opioid use disorders	Cross-Cutting Research	Small Business Programs	NIDA	NEURANO BIOSCIENCE	MOLOKANOVA, ELENA	Encinitas,CA	2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional) NOFO Number: RFA-DA-19-019 Summary: Novel therapies that could alleviate the severe symptoms of opioid withdrawal and/or reduce risk of relapse could help address the devastating opioid crisis. Memantine, an FDA-approved NMDA receptor antagonist, has shown encouraging results as an adjunct to existing opioid use therapies. Its therapeutic efficacy likely derives from its preferential binding to NMDA receptors located outside the synapse, since broad spectrum NMDA receptor antagonists are associated with multiple clinical side effects. This project will use a preclinical model to evaluate a nanostructured version of memantine (AuM) that physically prevents its binding to synaptic NMDA receptors but allows activation of extrasynaptic receptors with potency exceeding that of free memantine.
1R43DA050395-01	Fixed dose analgesic combination with non-opioid mechanism to prevent opioid misuse	Cross-Cutting Research	Small Business Programs	NIDA	SYNVENTA, LLC	GOMTSIAN, ARTOUR	Tucson, AZ	2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional) NOFO Number: RFA-DA-19-019 Summary: With nearly 116 million people suffering from chronic pain in the United States, there is a need for new analgesics without the risks posed by opioids. Antagonists acting at TRPV1 receptor have long been recognized as one of the most promising novel classes of non-opioid analgesics. Initial tests in humans have confirmed that this class of drugs produces analgesia and is safe and well-tolerated, but side effects include hyperthermia and partial loss of heat sensitivity, leading to most research being halted. This project will conduct a set of preclinical proof-of-concept studies in rats to support the claims that, at doses that have minimal, clinically acceptable, or negligible impact on cardiovascular function, a2 adrenoceptor agonists can diminish thermoregulatory effects of TRPV1 receptor antagonists.
1R43DA050397-01	Development of cannabinoid-opioid combination with opioid sparing and synergistic analgesic effects to prevent opioid use disorder and overdose.	Cross-Cutting Research	Small Business Programs	NIDA	BDH PHARMA, LLC	BRIONES, MARISA	Valley Village, CA	2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional) NOFO Number: RFA-DA-19-019 Summary: With the entwined crises of opioid use and chronic pain, there is a need for alternative, safe therapies to manage opioid use disorder, opioid withdrawal symptoms, chronic pain, and/or associated anxiety and depression. A proof-of-concept preclinical study has already been conducted of a cannabinoid-opioid combination that demonstrated opioid-sparing and synergistic analgesic effects, with the combination providing greater analgesia in a rodent model of chronic pain than a standard dose of the opioid alone. This proposal aims to develop a fixed-dose combination (FDC) of the cannabinoid-opioid that may have improved analgesia with lower opioid doses and thereby lower the risk of dependence, withdrawal, diversion, abuse, and overdose. Preclinical pharmacokinetic and ?in vivo ?safety studies will help determine if co-administration alters the pharmacokinetics and/or respiratory depression related to either compound in rodents.
1R43DA058430-01	Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy	Cross-Cutting Research	Small Business Programs	NIDA	OPALGENIX, INC.	PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR	Carmel, IN	2023
NOFO Title: Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional) NOFO Number: RFA-DA-23-021 Summary: There is an urgent and unmet clinical need for a reliable technology to prevent maternal opioid use relapse and neonatal opioid withdrawal syndrome (NOWS) in their infants. This project aims to assess risk for these outcomes based on individual genetic and clinical factors. The research will expand previous studies of genetic and clinical predictors of opioid-related adverse outcomes. The goal is to develop a risk predictor algorithm and software tool for use in an electronic health record, toward personalized risk assessment and prevention of maternal relapse and NOWS.
1R43DA058614-01	Combination Therapeutic for Chronic Opioid Use Disorder Relapse	Cross-Cutting Research	Small Business Programs	NIDA	APHIOS CORPORATION	CASTOR, TREVOR P	Woburn, MA	2023
NOFO Title: PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-22-176 Summary: Side effects from taking the opioid receptor blocker naltrexone make it difficult for patients to adhere to treatment with this medication for opioid use disorder. Cannabidiol (CBD), a bioactive ingredient of cannabis, is not an opioid and is non-psychoactive. Previous research shows that CBD blocks opioid-seeking behaviors, craving, and withdrawal. This project will develop tiny particles containing CBD and low-dose naltrexone. The research will determine if this combined version of CBD and naltrexone helps people stay in treatment and prevents relapse without problematic side effects.
1R43DE029369-01	A Novel Opioid-Free Targeted Pain Control Method for Acute Post-Operative Localized Pain Related to Oral Surgical Procedures	Cross-Cutting Research	Small Business Programs	NIDCR	LAUNCHPAD MEDICAL, LLC	JADIA, RAHUL; KAY, GEORGE	Boston, MA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: There is a compelling need to develop a front line, non-opioid-based acute pain management strategy for outpatient oral surgical procedures. LaunchPad Medical has developed Tetranite® (TN), a novel bone regenerative mineral-organic self-setting adhesive biomaterial. TN has been extensively studied in vivo in a canine jaw model and shown to be effective and well-tolerated. In this project, researchers will demonstrate that drug-loaded TN can be a novel route to providing localized and time release pain medication following wisdom tooth extraction by determining the release profile of various pain medications from TN at different concentrations. The ability to release pain therapeutics in a controlled fashion and directly at the site of injury offers improved pain control following oral surgical procedures without exposing the patient to opioids. This novel approach to pain management can be extended to more invasive orthopedic procedures such as joint replacement, spinal fusions or reconstructive trauma surgery. In Phase II the team will conduct an in vivo study to assess efficacy of medicated TN to address post-operative pain following wisdom tooth odontectomy, optimize incorporation and release of medications in TN formulations, develop cGMP manufacturing process for the compounded product, and ultimately conduct clinical trials for bone void filler using medicated TN.
1R43DE029379-01	Therapeutic in Situ Analgesic Implant for improved Oral-Facial Post-Operative Pain Outcomes	Cross-Cutting Research	Small Business Programs	NIDCR	EPIGEN BIOSCIENCES, INC.	FRIEDMAN, CRAIG; CAUDLE, ROBERT M	San Diego, CA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: Analgesia for post-operative populations remains a significant health need that calls for innovative therapies which improve both safety and outcome measures. Recent FDA drug safety warnings and studies focusing on post-operative analgesia have highlighted the imperative need for new approaches that can be utilized for common clinical scenarios. Accordingly, novel treatment options that are safe and afford additional benefit in relief of pain are needed. In this proposal, the development of an innovative surgical sealant technology is proposed that functions at the level of the surgical wound bed and actively delivers local pharmacologic agents to therapeutically address post-operative pain. New formulations of several analgesic regimens will be assessed for their ability to seal wounds and provide appropriate pain management.
1R43HD107727-01A1	Novel Approach to Personalize and Monitor Therapeutic Training At Home in Chronic Pelvic Pain Management	Cross-Cutting Research	Small Business Programs	NICHD	Hillmed, Inc.	DIAS, NICHOLAS	Katy, TX	2022
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed) NOFO Number: RFA-NS-20-011 Summary: Chronic pelvic pain is a debilitating condition that negatively affects the social and sexual quality of life for up to 20% of American women. Pelvic floor muscle (PFM) pain is caused by many factors, as well as by incorrect posture and excessive sensitization of the peripheral nervous system. This project will introduce a prototype of the Chronic Pelvic Pain (CPP) HomeTrainer that monitors, quantitatively and in real time, both PFM activation capacity and muscle interactions between the PFM and hip/trunk muscles and adapts the PFM training to the user’s needs in their own home. The proposed CPP HomeTrainer offers biofeedback to aid myofascial physical therapy and movement pattern training by tailoring the protocol to specifically correct interactions between the PFM and problematic hip/trunk muscles.
1R43HD111082-01A1	Novel Venous Device for the Treatment of Chronic Pelvic Pain	Cross-Cutting Research	Small Business Programs	NICHD	V-FLOW MEDICAL, INC.	BRENNEMAN, RODNEY	San Juan Capistrano, CA	2023
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed) NOFO Number: RFA-NS-20-011 Summary: Pelvic venous compression is a common cause of chronic pelvic pain in women. Because many women do not receive an accurate diagnosis for the cause of their pelvic pain, some take opioids to help manage their symptoms. This project will further develop a new diagnostic system specifically designed to treat limited blood flow in pelvic region. This system visualizes pelvic veins toward development of a method to relieve pressure that causes pain.
1R43HD112219-01A1	Targeted Temperature Modulation with Smart Radiometric Monitoring for Effective and Long-Lasting Opioid-Free Pelvic Pain Relief: A Novel Low-Cost, Portable, Tampon-Sized Thermal Transfer Device	Cross-Cutting Research	Small Business Programs	NICHD	H3PELVIC THERAPY SYSTEMS, INC.	LYON, ZACHARY W	Lewisville, NC	2023
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed) NOFO Number: RFA-NS-23-006 Summary: Pelvic pain (PP) includes more than 20 different painful and debilitating conditions, such as urinary tract infections, menstrual cramps, endometriosis, overactive bladder, and interstitial cystitis, and affects millions of people. Globally, pelvic pain affects 1 in 5 women and 1 in 12 men. This project will develop an instrument to monitor and treat pain-associated temperature changes in the pelvic region to reduce chronic pelvic pain. This novel system is intended to be used at home with personalized settings.
1R43HL167661-01A1	Improving Analgesic Effectiveness and Safety with Proactive Precision Pain Management in Thoracic Surgical Patients with Lung Lesions	Cross-Cutting Research	Small Business Programs	NHLBI	OPALGENIX, INC.	PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR	Indianapolis, IN	2023
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed) NOFO Number: RFA-NS-20-011
1R43HL167661-01A1	Improving Analgesic Effectiveness and Safety with Proactive Precision Pain Management in Thoracic Surgical Patients with Lung Lesions	Cross-Cutting Research	Small Business Programs	NHLBI	OPALGENIX, INC.	PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR	Carmel, IN	2023
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed) NOFO Number: RFA-NS-20-011 Summary: Thoracic (chest) surgeries often cause both short-term (acute) and long-term (chronic) pain and long-term opioid use. Unique genetic and clinical risk factors affect individual responses to surgical pain and pain medications. Current trial-and-error approaches to managing post-surgical pain and opioid prescribing are not ideal. This project will develop predictive software within a medical device that takes into account an individual’s genetic and clinical information to predict the likelihood of chronic pain following thoracic surgery.
1R43NR017575-01A1	Using Virtual Reality Psychological Therapy to Develop a Non-Opioid Chronic Pain Therapy	Cross-Cutting Research	Small Business Programs	NINR	COGNIFISENSE, INC.	BAEUERLE, TASSILO; CEKO, MARTA ; WEBSTER, LYNN	Sunnyvale, CA	2019
NOFO Title: PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) NOFO Number: PA-17-302 Summary: Chronic pain affects over 100 million Americans, costing society about $600 billion annually. Despite numerous pharmacological and non-pharmacological therapies, over 50% of chronic pain sufferers feel little control over their pain. CognifiSense has developed a patent-pending Virtual Reality Psychological Therapy (VRPT), which is designed to create lasting reduction of chronic pain by addressing the maladaptive learning processes driving pain chronification. VRPT is an experiential learning system, which provides the brain a new set of signals that teaches it that the pain is not as bad as it perceived and that it has greater control over the pain than it perceived. VRPT combines the immersive power and the ability to individualize the therapy of Virtual Reality with well-researched principles of self-distancing, self-efficacy, and extinction to retrain the brain. The goal of this study is to determine the clinical feasibility of VRPT in achieving a lasting reduction of chronic pain, establish brain mechanisms associated with treatment response, and collect comprehensive user feedback to enable further refinement of the current product prototype. CognifiSense's VRPT has the potential to be a significant clinical and business opportunity in the treatment of chronic pain.
1R43NS110117-01	Development of a novel anti-migraine therapeutics	Cross-Cutting Research	Small Business Programs	NINDS	ADEPTHERA, LLC	HSU, SHEAU-YU TEDDY	Palo Alto, CA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: New approaches that can effectively ameliorate acute and chronic migraine pain are urgently needed. Due to its critical roles in inducing migraine pain, CGRP and its receptor complex, the calcitonin receptor-like receptor (CLR) and receptor activity-modifying protein 1 (RAMP1) have been targeted for migraine treatment. A new strategy for targeting the CGRP-mediated signaling pathway is needed to meet the medical need of migraine patients. The team developed a group of long-acting CGRP/RAMP1-specific peptide super-antagonists that form gels in situ in aqueous solution. Based on this exciting finding, the investigators propose to develop and identify the most potent antagonistic analog candidates (Aim 1), and characterize the pharmacokinetics of gel depots made of the selected candidates in vivo (Aim 2). This feasibility study is needed to explore the translational potential of these newly invented super-antagonists for the treatment of chronic migraine in combination with conventional migraine agents.
1R43NS112088-01A1	Repression of Sodium Channels via a Gene Therapy for Treatment of Chronic Neuropathic Pain	Cross-Cutting Research	Small Business Programs	NINDS	NAVEGA THERAPEUTICS, INC.	MORENO, ANA MARIA; ALEMAN GUILLEN, FERNANDO	San Diego, CA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: Voltage-gated sodium channels are responsible for the transmission of pain signals. Nine genes have been identified, each having unique properties and tissue distribution patterns. Genetic studies have correlated a hereditary loss-of-function mutation in one human Na+ channel isoform – ?Na?V?1.7 – with a rare genetic disorder known as Congenital Insensitivity to Pain (CIP). Individuals with CIP are not able to feel pain without any significant secondary alteration. Thus, selective inhibition of ?Na?V?1.7 in normal humans could recapitulate the phenotype of CIP. This research team developed a non-permanent gene therapy to target pain that is non-addictive (because it targets a non-opioid pathway), highly specific (only targeting the gene of interest), and long-term lasting (around 3 weeks in preliminary assays in mice). During this Phase I , the team will 1) test additional pain targets ?in vitro?, and 2) evaluate the new targets ?in vivo ?in mice models of inflammatory and neuropathic pain.
1R43NS113726-01	Pharmacokinetic and toxicology studies of AYX2, a transcription factor decoy, non-opioid, disease modifying drug candidate for the long-term treatment of chronic pain	Cross-Cutting Research	Small Business Programs	NINDS	ADYNXX, INC.	MAMET, JULIEN	San Francisco, CA	2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) NOFO Number: PA-18-574 Summary: Chronic focal neuropathic pain, which includes pain etiologies such as radiculopathy and radiculitis, focal peripheral neuropathies, and low back pain, affects as many as 25 million patients annually in the United States. Chronic focal neuropathic pain is maintained by genome-wide transcription regulation in the dorsal root ganglia (DRG) / spinal cord network. The transcription factors driving this regulation constitute a promising class of targets with the potential to alter the course of pain with a single treatment. DNA decoys are oligonucleotides that specifically inhibit the activity of certain transcription factors. AYX2 binds and inhibits Krüppel-like transcription factors (KLF) in the DRG-spinal cord. The goal of this Phase 1 proposal is to advance AYX2 toward an IND submission, allowing for human clinical trials. We propose in Aim 1 to characterize AYX2 pharmacokinetics in the cerebrospinal fluid and plasma and its distribution in the DRG, spinal cord and brain following an IT injection. With this information, AYX2 will be tested in a panel of complementary toxicology studies in Aim 2 to allow for final IND-enabling studies, supported by Phase 2 of the grant. This research will accelerate development of AYX2 as a novel drug candidate for the non-opioid treatment of pain.